Kornimate/medical-research-clean huggingface dataset:
nutrition of premature infants with human breastmilk fortifier

Conditions: Growth Acceleration

Summary: the objective of the study is to compare two human milk fortifiers with different protein content and lcpufa in a group of very low birth weight infants.

this study is a multi-center, third party-blinded, randomized, controlled, parallel- group, prospective trial comparing growth with a liquid human milk fortifier with higher protein content and lcpufa and a control powdered human milk fortifier added to breast milk and fed to premature infants. the trial will be conducted in 11 centers in chile. the enrollment period is expected to be approximately 18 months. to allow for dropouts, approximately 160 participants will be randomized.

Eligibility criteria:
inclusion criteria: * premature infant equal or under 31 weeks gestational age at birth * birth weight equal or under 1,250 g * predominantly fed breast milk (mother's milk or donor milk) on study day 0 * appropriate birth weight for gestational age (aga) - defined as birth weight between and inclusive of the 10th and 90th percentiles on the fenton growth chart * singleton or twin birth (both twins do not need to qualify and be randomized into study) * birth weight is ≤1,000 g and participant is ≤ 40 days of age on study day 0 * birth weight is above 1,000 g and participant is ≤ 30 days of age on study day 0 * enteral intake of 80 ml/kg/d of unfortified breast milk on study day 0 * anticipate mother's willingness to breast milk for at least 28 days from study day 0 * signed informed consent obtained exclusion criteria: * history of underlying metabolic or chronic disease, congenital malformation, or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the participant to ingest food, normal growth and development of the participant, or the evaluation of the participant * 5 minute apgar score ≤ 4 * major surgery that required general anesthesia prior to first day study (note: persistent ductus arterious ligation is allowed) * received pharmacologic doses of glucocorticoids during 3 consecutive days (72 hours) prior to or on day one of study (physiologic hydrocortisone administration up to 1.5 mg/kg/d is permitted) * ventilator-dependent and requiring ≥ 40% fraction of inspired oxygen (fio2) on day one of study (ventilator dependent and requiring ≤ 40% fio2 and/or nasal canula, and/or nasal continous positive airway pressure (cpap) and/or oxygen hood is allowed) * grade iii or iv bilateral intraventricular hemorrhage (ivh) prior to or on study day one * feeding intolerance to breast milk feedings on study day one * consumption of more than 3 feedings or 12 hours of continuous feeds of fortified breast milk prior to study day one * fluid restriction \< 120 ml/kg/d * history of creatinine \>2.0 mg/dl 7 days prior to or on study day one * currently receiving or plan use of probiotics
the role of fractional vascular laser therapy in the management of burn scars

Conditions: Burn Scar

Summary: while the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. for this reason, our assessing the effects of fractional vascular lasers on burn scars. it has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. the retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft). objective: to determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.


Eligibility criteria:
inclusion criteria: * living in winnipeg * burn scar 6-12 months old * fitzpatrick skin type i-iii * thermal burn scar on trunk or extremities exclusion criteria: * open wound

Keywords: burn scar laser fractional vascular
examining the effectiveness of eal

Conditions: Trauma

Summary: this quasi-experiment will evaluate the effectiveness of equine assisted learning for reducing symptoms associated with trauma exposure among public safety personnel (e.g., fire fighters, police, paramedics, etc.).

the purpose of the proposed project is to investigate the effectiveness of equine assisted learning (eal) for reducing symptoms associated with trauma exposure among public safety personnel. eal is an intervention in which mental health clinicians and equine specialists work together with clients to address a learning goal via unmounted interaction with a horse. recent literature indicates that eal shows promise in addressing a range of mental health diagnoses among a variety of populations, including military and royal canadian mounted police veterans with ptsd. the eal intervention will be delivered at cartier farms in spruce home, saskatchewan. research components of this study will be conducted virtually via zoom. the investigators will employ a quasi-experimental design with pre-post and follow-up testing. participants will be assigned one of two groups based on the time that they complete their initial baseline interview: (1) the intervention group will receive the eal intervention for 8 weeks, while (2) the waitlist control condition will not receive this treatment for the same amount of time. data on trauma exposure symptom severity will be collected from all participants prior to the start of the the study (baseline), again 8 weeks later (post), and then a final time 3 months later (follow-up). the two conditions will then be compared to determine whether there are differences in trauma exposure symptom severity between groups. to obtain a sufficient sample size while also running appropriately sized interventions of 6-10 participants per session, the researchers will conduct 4-6 rounds of group assignment. all individuals in the waitlist control condition will be offered eal following their completion of the study.

Eligibility criteria:
inclusion criteria: 1. english-speaking adults; 2. currently or previously employed as public safety personnel (e.g., police officer, fire fighter, paramedic, healthcare worker, emergency dispatcher, correctional officer); 3. reside in saskatchewan; 4. meet diagnostic criteria for having experienced a criterion a traumatic event; 5. able to provide written informed consent; 6. have access to a smart phone, tablet, or computer with a working microphone and camera; and 7. have access to consistent and reliable internet. exclusion: 1. meet/met current/past diagnostic criteria for several psychiatric, neurodevelopmental, and neurological conditions; 2. history of severe head trauma with loss of consciousness or history of traumatic brain injury; 3. have previously completed at least half of the eal curriculum at cartier farms.

Keywords: eal ptsd posttraumatic stress disorder public safety personnel first responder equine assisted learning horse therapy trauma
open-label study to evaluate safety, tolerability and pk of bhv-0223 in als

Conditions: Amyotrophic Lateral Sclerosis; ALS; Lou Gehrig Disease; Lou Gehrig's Disease; Lou-Gehrigs Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary: phase 1, open-label study of bhv-0223 in als.

this is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of bhv-0223 in subjects with als.

Eligibility criteria:
inclusion criteria: 1. subjects with diagnosed als by the revised el escorial diagnostic criteria, including laboratory supported probable, probable, or definite als; 2. subjects who have never taken riluzole tablets, or subjects who previously took riluzole tablets but discontinued at least 1 month prior to the screening visit. subjects must not have had alt or ast \> 5 x uln while taking riluzole tablets, or any other clinically significant tolerability issues (e.g., hypersensitivity reactions) in the judgement of the investigator; 3. subjects determined by the investigator to be medically stable; 4. subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance. exclusion criteria: 1. target disease exceptions 2. medical history exceptions 1. subject is known to have a current diagnosis of acute or chronic viral hepatitis; 2. subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment; 3. subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment; 4. any other sound medical, psychiatric and/or social reason in the investigator's judgment; 3. physical and laboratory test findings 1. positive urine pregnancy test in wocbp at screening; 2. subject has evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or other determinations beyond what is consistent with the target population, in the investigator's judgment; 3. subject has liver function testing abnormalities (alt, ast , or total bilirubin) that are \> 1 x uln; 4. other exclusions a. subjects who are unable to be compliant with the visit schedule or protocol procedures.

Keywords: amyotrophic lateral sclerosis als biohaven motor neuron disease, amyotrophic lateral sclerosis lou gehrig's disease lou-gehrigs disease lou gehrig disease riluzole rilutek® neuroprotective agents administration, sublingual administration, oral biological availability
study of dexmedetomidine in spine surgery

Conditions: Collapse of Thoracic Vertebra; Collapse of Lumbar Vertebrae

Summary: the investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. the investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. the incidence of intra and postoperative complications will be assessed.

patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (mep/ssep/emg)will be recruited. standard anesthesia monitoring will be performed. randomized to a placebo or dexmedetomidine arm. both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia. the placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure. intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team. upon closure the study drug will be terminated. patients will be followed up for 72 hours after surgery. total opiate consumption and visual analogue scale ratings will be documented. intra and postoperative inotrope/pressor requirements will be recorded.

Eligibility criteria:
inclusion criteria: * age 18-80 years of age * elective multi-level thoracic and/or lumbar spine surgery requiring ssep, emg or mep monitoring exclusion criteria: * emergency spine surgery * age \< 18 years * pregnant patients * advanced heart block: mobitz type ii block or atrio-ventricular dissociation in a previous ekg. * any individual with stage 4 or greater chronic kidney disease (egfr\< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure * any individuals on preoperative methadone therapy * preoperative dexmedetomidine use * preoperative systolic hypertension defined by a systolic blood pressure greater than 150 mmhg in the surgical admission suite * enrolled in another study within 30 days

Keywords: opiate consumption visual analogue scale
prophylactic norepinephrine infusion combined with colloid coloading for postspinal anesthesia hypotension

Conditions: Adverse Event

Summary: the purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. as a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. but the ideal infusion dose of norepinephrine with colloid coload is still unknown. the purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility criteria:
criteria: inclusion criteria: * 18-40 years * primipara or multipara * singleton pregnancy ≥ 37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for elective cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmhg * hemoglobin \< 7g/dl * coagulation or renal function disorders * known allergy to hydroxyethyl starch * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine hydroxyethyl starch postspinal anesthesia hypotension coload cesarean section
application of diffusion weighted mri versus ct in evaluation of the effect of treating lung cancer

Conditions: Lung Neoplasms

Summary: the purpose of this study is to investigate the diagnostic accuracy of adc value of diffusion weighted mri in comparison of conventional treatment assessment criteria in evaluation of chemotherapy. moreover, the investigators aim to clarify the correlation of adc value with histologic type and grade of lung cancer and survival of patients.

in recent years, lung cancer is an aggressive and heterogeneous disease, advances in surgical and chemotherapeutic approaches have been made, but the long-term survival rate remains low. although effective mass screening of high-risk groups could potentially be of benefit, randomized trials of screening with the use of chest radiography with or without cytological analysis of sputum specimens have shown no reduction in lung-cancer mortality. currently, response evaluation criteria in solid tumors (recist) by ct is the most commonly used to evaluate chemotherapy of lung cancer patient, but patients have to be exposed to radiation. for this reason, the investigators aim to assess the diagnostic accuracy of apparent diffusion coefficient (adc) value, a specific parameter of radiation-free diffusion weighted mri, in comparison of recist, and its correlation with histologic type and grade of lung cancer as well. furthermore, the investigators investigate its correlation with progression free survival (pfs) and overall survival (os) in patients.

Eligibility criteria:
inclusion criteria: 1. age: 18-75 2. patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells) 3. after clinical assessment, patients who need chemotherapy (tumor stage iii or iv of lung cancer or others who are reluctant to receive pneumonectomy); 4. patients have no previous history of chemotherapy 5. patients with at least one clearly measurable lung lesion (lesion size larger than 10mm, by spiral ct, according to recist) 6. health status scoring between 0-2 by eastern cooperative oncology group(ecog) method 7. patients voluntarily to join this study and signed informed consents. exclusion criteria: 1. any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves 2. patients with claustrophobia to mri or ct examination 3. patients who are reluctant to comply with follow-up and subsequent examination 4. the other condition that do not meet the inclusion criteria.

Keywords: lung neoplasms diffusion weighted mri adc value treatment effect
intravitreal conbercept for idiopathic choroidal neovascularization

Conditions: Idiopathic Choroidal Neovascularization

Summary: the purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-vegf) therapy as primary treatment for icnv.


Eligibility criteria:
inclusion criteria: * patient who give voluntary signed informed consent * patient affiliated with the tianjin medical university eye hospital or similar * patient with icnv with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or sd-oct in the studied eye * patient willing, committed and able to return for all clinic visits and complete all study-related procedures exclusion criteria: * pregnant women * sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study * patient who is protected adults according to the terms of the law (french public health laws) * involvement in another clinical trial (studied eye and/or the other eye) * patient with non-icnv, especially: * amd * high myopia defined as refraction ≥ - 6 diopters * other curative treatment of icnv in the studied eye during the last 3 months before the first intravitreal injection: anti-vegf therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ... * medical history of retrofoveal focal macular laser photocoagulation in the studied eye * subretinal haemorrhage reaching the fovea centre, with a size \> 50% of the lesion area * fibrosis or retrofoveal retinal atrophy in the studied eye * retinal pigment epithelial tear reaching the macula in the studied eye * medical history of intravitreal medical device in the studied eye * medical history of auto-immune or idiopathic uveitis * proved diabetic retinopathy * intra-ocular pressure ≥ 25 mmhg despite two topical hypotonic treatments * aphakia or lack of lens capsule (not removed by yag laser) in the studied eye * arterial hypertension that is not controlled by an appropriate treatment * previous or actual treatment with systemic administration of anti-vegf therapy * known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops * active or suspected ocular or peri-ocular infection * serious active intra-ocular inflammation in the studied eye * medical history of intra-ocular surgery within 28 days before the first injection in the studied eye * any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion * follow up not possible during 12 months
myocellular signalling in skeletal muscle

Conditions: Exercise; Insulin Sensitivity

Summary: the study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men


Eligibility criteria:
inclusion criteria: * healthy * informed consent * habitual training (2-5 h/week) * vo2max of 40-60 ml/min/kg * lean mass 55-65 kg exclusion criteria: * smoker * allergy towards insulin * chronic disease
effect of exercises on dynamic balance in knee osteoarthritis patients.

Conditions: Knee Osteoarthritis

Summary: this study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.


Eligibility criteria:
inclusion criteria: * the patient's age \> 50 years. * recent radiographs confirming the presence of knee oa, grade ii-iii (mild to moderate) kellgren lawrence (k/l). * body mass index (bmi) from 20 to 30 kg/m2. * met the american college of rheumatology clinical criteria for mild to moderate knee oa. * knee pain \> 3 cm on a 10 cm visual analog scale (vas) on most days of the previous week. * bilateral knee osteoarthritis. exclusion criteria: * congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee. * patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests. * intra articular knee injection of steroids in the past 6 months. * patients who had received joint replacement surgery in either knee or hip. * patients with rheumatoid arthritis. * patients who received physical therapy sessions on the knee in the past 6 months.
a study of evorpacept (alx148) with azacitidine for higher risk myelodysplastic syndrome (aspen-02)

Conditions: Higher Risk Myelodysplastic Syndromes

Summary: this phase 1/2 clinical study will evaluate evorpacept (alx148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (mds).

the phase 1 will consist of a dose escalation of evorpacept (alx148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended phase 2 dose of alx148 in combination with azacitidine. the phase 2 will evaluate the efficacy of evorpacept (alx148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk mds.

Eligibility criteria:
inclusion criteria: * phase 1: diagnosis of higher risk mds that is either previously untreated or relapsed/refractory. * phase 2: diagnosis of higher risk mds that is previously untreated. * adequate renal and liver function. * age ≥18 years. * adequate performance status. exclusion criteria: * previous allogeneic hematopoietic stem cell transplant (allo-hsct) for mds or aml. * prior treatment with any anti-cd47 or anti-sirpα (signal regulatory protein alpha) agent. * known active viral infections, including hepatitis b and c, human immunodeficiency virus (hiv), acquired immunodeficiency syndrome (aids) related illness, or sars-cov-2 (severe acute respiratory syndrome coronavirus 2).

Keywords: alx148 mds cd47 azacitidine hma sirp-alpha evorpacept high risk